NCT07407413

Brief Summary

In this Edu:Social Health Care project, a randomized controlled trial with a socio-emotional intervention and a waitlist control group will be conducted to evaluate the effects of a partner-based empathy-compassion Dyad mental training (EmCo) intervention on healthcare students with regard to the following primary outcome domains: 1) mental health, 2) resilience, 3) social cohesion and support, 4) social skills, 5) coping and emotion regulation, and 6) social behaviors. One main goal is to examine the effects of such adapted 8-week EmCo Dyad intervention within the health care context, with a particular focus on strengthening students' mental health, resilience, social skills and behaviors, and social cohesion as well as fostering interprofessional attitudes by pairing every week study partners across different healthcare disciplines with each other for practicing their daily Dyads (e.g., nursing students will practice daily via app with medical students). A further aim is to validate the novel Dyad Voice Assessment (DYVA) task, which explores the use of app-based voice recordings as indicators of students' emotional states during their daily partner-based Dyad practice. By combining students' self-reported practice-related emotions with partner-based evaluations, this approach aims to generate new and innovate, more objective markers of training-induced changes in emotional processing and regulation over time in a real-live applied setting. The final aim is to investigate the cognitive and affective mechanisms and factors underlying observed changes in students' mental health, resilience, social cohesion, social skills and social behaviors, that may explain observed training-related effects in primary outcome domains. Based on previous research, we expect the socio-emotional EmCo Dyad training to activate evolutionary old care- and affiliation-based motivational systems that foster positive affect and motivation, acceptance, trust social capacities and behavioral tendencies. These processes should go along with reduction in loneliness, stress and other mental vulnerabilities (anxiety, depression, burn-out etc.) and foster social skills such as empathy, compassion as well as social cohesion and resilience.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Feb 2026Oct 2026

First Submitted

Initial submission to the registry

January 12, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 16, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2026

Last Updated

February 12, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

January 12, 2026

Last Update Submit

February 5, 2026

Conditions

Keywords

Mental TrainingDyad TrainingCompassionate-ListeningEmpathic-ListeningEmpathyCompassionMental-HealthOnline & App-based TrainingResilienceSocial CohesionSocial KillsAI-based Voice AssessmentHealthcare students

Outcome Measures

Primary Outcomes (17)

  • Depression Anxiety Stress Scale (DASS-21)

    A scale measuring depression, anxiety, and stress (Henry \& Crawford, 2005; Nilges \& Essau, 2021). Higher scores indicate more depression, anxiety, and stress.

    Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)

  • Maslach Burnout Inventory-Students Survey (MBI-SS)

    A scale measuring burnout (Gumz et al., 2013; Maslach \& Jackson, 1981). Higher scores indicate more burnout.

    Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)

  • UCLA Loneliness Scale (UCLA)

    A scale measuring loneliness severity (Döring \& Bortz, 1993; Russell et al., 1980). Higher scores indicate more loneliness.

    Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)

  • Connor Davidson Resilience Scale (CD-RISC)

    A scale measuring psychological resilience (Connor \& Davidson, 2003; Sarubin et al., 2015). Higher scores indicate more resilience.

    Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)

  • Social closeness (IOS per profession)

    A scale measuring the felt closeness between persons or groups/communities using a visual representation (Aron et al., 1992; Kinnunen \& Windmann, 2013). Higher score indicates more social closeness.

    Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)

  • Interprofessionalism Scale (IPAS-D)

    A scale (Norris et al., 2015; Pedersen et al., 2020) measuring attitudes that relate to the Core Competencies for Interprofessional Collaborative Practice (IPEC Report, 2011). Higher scores indicate more positive attitudes toward collaborative practice.

    Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)

  • Social Support Scale (F-SozU K-6)

    A scale measuring the subjective feeling of having support available (Kliem et al., 2015). Higher scores indicate greater perceived social support.

    Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)

  • Socio-Affective Video Task (SoVT)

    This task assesses behavioral empathy and compassion using emotional video clips (Klimecki et al., 2014). Higher scores indicate more empathy or more compassion.

    Assessed at baseline (pre-test), after 4 weeks of empathic listening training (mid-intervention) and after the 4 weeks of compassionate listening training (post-test 1 & 2)

  • Sussex-Oxford Compassion Scale for Self and Others (SOCS)

    A scale measuring self-compassion (SOCS-S) and compassion for others (SOCS-O; Gu et al., 2020). Higher scores indicate more compassion.

    Assessed at baseline (pre-test), after 4 weeks of empathic listening training (mid-intervention) and after the 4 weeks of compassionate listening training (post-test 1 & 2)

  • Mentalization Scale (MENTS)

    A scale measuring the capacity of envisioning one's and others' behaviors with reference to the underlying mental states (Dimitrijević et al., 2018). Higher scores suggesting a more sophisticated capacity for mentalizing.

    Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2).

  • Prosodic Features of Vocalized Emotional Expressions

    Acoustic assessment of prosodic speech features during participants' daily Dyad practice, analyzed using audEERING devAIce software. The following parameters will be assessed: pitch (Hz), loudness (unitless), speaking rate (syllables per second), and intonation (unitless).

    Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)

  • Affect Dimensions of Vocalized Emotional Expressions

    Assessment of continuous affective dimensions of vocalized emotional expressions during participants' daily Dyad practice using audEERING devAIce software. The following parameters will be assessed: arousal, valence, and dominance (each ranging from -1 to 1). Based on arousal-valence scores, the following affect quadrant values will be calculated: high-arousal-high-valence, low-arousal-high-valence, low-arousal-low-valence, and high-arousal-low-valence.

    Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)

  • Affect Categories of Vocalized Emotional Expressions

    Classification of vocalized emotional expressions into affect categories during participants' daily Dyad practice using audEERING devAIce software. The following categories will be assessed: angry, happy, and sad, expressed as unitless values ranging from 0 to 1 representing category likelihood.

    Assessed weekly from week 1 to week 8, as part of the Dyad Voice Assessment (DYVA)

  • Stress intensity

    Custom items based on the Stress Appraisal Measure (SAM; Delahaye et al., 2015; Peacock \& Wong, 1990) measuring stress intensity. Higher scores indicate more intense stress.

    Assessed using an EMA design with five push-notification measurements per day, distributed across five 3-hour intervals, on four days within a two-week period, at pre-test (Baseline) and after the 8-week intervention period (post-intervention).

  • Coping strategies

    Custom items based on the Brief-COPE (Carver, 1997; Knoll et al., 2005) and Cognitive Emotion Regulation Questionnaire (CERQ; Garnefski et al., 2001; Loch et al., 2011) measuring Coping Strategies (Acceptance, Positive Reinterpretation, Social Support, Rumination, Self-Blame, Distraction). Higher scores indicate a higher use of the specified coping strategies.

    Assessed using an EMA design with five push-notification measurements per day, distributed across five 3-hour intervals, on four days within a two-week period, at pre-test (Baseline) and after the 8-week intervention period (post-intervention).

  • Active Empathic Listening Scale (AELS)

    A scale measuring active empathic listening (Bodie, 2011). Higher scores indicate more active empathic listening.

    Assessed at baseline (pre-test), after 4 weeks of empathic listening training (mid-intervention) and after the 4 weeks of compassionate listening training (post-test 1 & 2)

  • Attachment behavior (ASQ)

    A self-report questionnaire measuring attachment-related behaviors in interpersonal relationships, including proximity seeking, avoidance, and security (Hexel, 2004). Higher scores indicate more pronounced attachment-related behaviors.

    Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)

Secondary Outcomes (20)

  • Positive Affect (Affect Grid) (explanatory mechanism)

    Assessed weekly during the course of 8 weeks of intervention

  • Emotion Acceptance (EAQ) (explanatory mechanism)

    Assessed weekly during the course of 8 weeks

  • Gratitude Questionnaire-6 (GQ-5-G) (explanatory mechanism)

    Assessed weekly during the course of 8 weeks

  • Self-Kindness Scale (SCS-SF) (explanatory mechanism)

    Assessed weekly during the course of 8 weeks

  • Positive Interpretation Bias (ERT) (explanatory mechanism)

    Assessed at baseline (pre-test) and after the 8-week intervention period (post-test 1 & 2)

  • +15 more secondary outcomes

Other Outcomes (5)

  • Patient Health Questionnaire (PHQ-9; pre-screening)

    Assessed before the intervention, only once, to pre-screen out from the study individuals who have clinical levels of depressive symptoms

  • Generalized Anxiety Disorder (GAD-7; pre-screening)

    Assessed prior to the intervention, only once, to pre-screen out from the study individuals who have clinical levels of anxious symptoms

  • Toronto Alexithymia Scale (TAS-20; pre-screening)

    Assessed before the intervention, only once, to pre-screen out from the study individuals who have high levels of alexithymia

  • +2 more other outcomes

Study Arms (2)

Empathy- and compassion-based socio-emotional mental training (EmCo)

EXPERIMENTAL

The socio-emotional intervention will consist of two 1.5h online onboarding I and II sessions and then 8 weeks of weekly 1.5-hour online coaching sessions with expert teachers as well as daily dyad practice with a partner over 8 weeks.

Behavioral: Experimental: Empathy- and compassion-based socio-emotional mental training (EmCo)

Waitlist Control Group (WCG)

OTHER

Initially, participants in the waitlist control group will not receive the intervention and will be offered the EmCo training only after the intervention group has completed the EmCo training program.

Other: Waitlist Control Group (WCG)

Interventions

1. Participants engage in a structured 13-minute partner-based contemplative exercise. Each dyad reflects on two experiences from the previous 24 hours: one involving a difficult emotion and one involving gratitude. Partners take turns speaking while the other listens non-judgmentally. During weeks 1-4, the practice emphasizes empathic listening; during weeks 5-8, compassionate listening. Participants are instructed to attend to bodily sensations associated with the emotions described. The practice aims to improve coping with difficult emotions, empathic and compassionate listening, (self)acceptance, compassion, gratitude, resilience. 2. Participants also attend eight 1.5-hour online group sessions led by Expert Dyad teachers. The coaching sessions help deepen the Dyad practice and educate teachers about body language, coping better with difficult emotions/stress, the benefits of empathy versus compassion and the act of listening from a mindset of empathy versus compassion.

Empathy- and compassion-based socio-emotional mental training (EmCo)

Participants in the control group will not receive the intervention. They will complete pre- and post-test procedures consisting primarily of self-report questionnaires, and behavioral tasks, as well as ecological momentary assessment (EMA) conducted on four days within two weeks at pre-test and post-test 1 \& 2.

Waitlist Control Group (WCG)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 18- and 65-years old.
  • actively enrolled student at the PMU.
  • Proficient in German.
  • Informed consent.
  • No symptoms of psychiatric disease within the past two years.
  • Stable internet access and necessary technical equipment (computer or laptop or tablet, and mobile phone with internet access).
  • No regular contemplative practice (≤ 50 hours total within the past six months); healthy population, non-clinical population.

You may not qualify if:

  • Insufficient German proficiency.
  • Lack of stable internet access or required devices (computer or laptop or tablet, and mobile phone with internet access).
  • No informed consent.
  • Not actively enrolled at PMU.
  • Regular contemplative practice (\> 50 hours in the past six months (e.g., dyad, mindfulness, compassion-based practices).
  • Current psychiatric diagnosis or therapy, or reaching screening cutoffs on:
  • Patient Health Questionnaire-9 (PHQ-9; Martin et al., 2006; Löwe et al., 2004; Cutoff ≥ 10),
  • Generalized Anxiety Disorder-7 (GAD-7; Löwe et al., 2007; Spitzer et al., 2006; Cutoff ≥ 10),
  • Toronto Alexithymia Scale-20 (TAS-20; Bagby et al., 1994; Ritz \& Kannapin, 2000; Cutoff ≥ 61)
  • Standardized Assessment of Personality - Abbreviated Scale (SAPAS; Moran et al., 2003; Söchtig et al., 2012, Cutoff ≥ 4).
  • Moreover, participants endorsing suicidality on the PHQ-9 will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (78)

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    BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Tania Singer, Ph.D.

    Social Neuroscience Lab, Max Planck Society

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lab Manager Social Neuroscience Lab

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
After pre-screening and randomized allocation to the two groups, participants and coordination staff need to be aware of which intervention arm (EmCo intervention group or WCG group) the participant belongs to in order to be able to group into appropriate coaching slots and onboarding I and II sessions prior to starting the actual 8-week online interventions with daily Dyad practice. Outcome assessors and investigators remain blinded to participant allocation for the duration of the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

February 12, 2026

Study Start

February 16, 2026

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

October 10, 2026

Last Updated

February 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share